WO2011033750A1 - Treatment device for urination disorders - Google Patents

Treatment device for urination disorders Download PDF

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Publication number
WO2011033750A1
WO2011033750A1 PCT/JP2010/005550 JP2010005550W WO2011033750A1 WO 2011033750 A1 WO2011033750 A1 WO 2011033750A1 JP 2010005550 W JP2010005550 W JP 2010005550W WO 2011033750 A1 WO2011033750 A1 WO 2011033750A1
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WIPO (PCT)
Prior art keywords
stimulation
treatment device
electrodes
urination disorder
sacrum
Prior art date
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PCT/JP2010/005550
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French (fr)
Japanese (ja)
Inventor
高木愛理
久本隆
Original Assignee
パナソニック株式会社
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Application filed by パナソニック株式会社 filed Critical パナソニック株式会社
Priority to JP2011531782A priority Critical patent/JP5548688B2/en
Priority to US13/496,694 priority patent/US20120197339A1/en
Priority to DE112010003698T priority patent/DE112010003698T5/en
Publication of WO2011033750A1 publication Critical patent/WO2011033750A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A61B5/202—Assessing bladder functions, e.g. incontinence assessment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0408—Use-related aspects
    • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36031—Control systems using physiological parameters for adjustment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]
    • A61B5/391—Electromyography [EMG] of genito-urinary organs

Definitions

  • the present invention relates to a urination disorder treatment device for treating urination disorder.
  • the conventional urination disorder treatment device has a configuration in which a pair of stimulation electrodes arranged at a predetermined distance on the dorsal surface of the sacrum supply a stimulation signal from a stimulation signal source. According to the stimulation signal, the bladder and the urethral portion are stimulated via the nerve responsible for urine collection passing through the sacral urination reflex center to alleviate urination disorder.
  • a pair of stimulation application electrodes must be disposed at an appropriate part of the sacral dorsal surface. This is because if the pair of stimulus applying electrodes are not properly positioned, it is not possible to apply an appropriate stimulus to the bladder and the urethra part.
  • the conventional urination disorder treatment device it may not be possible to determine whether or not the stimulation application electrode can be disposed at an appropriate position, and an appropriate treatment may not be performed.
  • the present invention is capable of performing appropriate treatment of urination disorder by making it possible to determine whether the stimulus applying electrode is properly disposed and whether or not the nerve that controls urine storage is applying the appropriate stimulus. It aims to provide a disorder treatment device.
  • the urination disorder treatment device of the present invention has the following configuration. 1) At least one pair of stimulation electrodes arranged on the back of the patient's sacrum via a predetermined interval and supplying stimulation signals to the back of the sacrum; 2) a stimulation signal source for the pair of stimulation electrodes to supply a stimulation signal; 3) a stimulation transmitting detection electrode which is disposed in the vicinity of a tissue connected by a nerve passing through the sacrum or the vicinity of the sacrum, and detecting a biosignal generated in response to the stimulation signal; 4) a ground electrode placed on any skin of the patient; 5) a measurement unit connected to the stimulation transfer detection electrode and the ground electrode and measuring a biological signal detected by the stimulation transfer detection electrode; 6) A control unit connected to the measurement unit and controlling supply of the stimulation signal by the pair of stimulation application electrodes based on the measurement result of the measurement unit; 7) Display means connected to the control unit and displaying the measurement result by the measurement unit.
  • the urinating disorder treatment device of the present invention it can be determined whether or not a pair of stimulation applying electrodes transmit an appropriate stimulus to the nerve responsible for urination passing through the urination reflex center of the sacral region. Specifically, by measuring the biosignal to the sacral dorsal stimulation with the stimulation transfer detection electrode and the measurement unit, it is possible to confirm whether or not the appropriate stimulation is performed. Therefore, effective treatment is realized.
  • the urinating disorder treatment device of the present invention it can be judged from the information displayed on the display means whether or not the appropriate stimulus is transmitted to the nerves in which the pair of stimulus application electrodes manage urine storage. .
  • the therapist (which may be the patient himself) can apply an appropriate stimulus by correcting the arrangement position of the pair of stimulus applying electrodes to an appropriate position based on the information displayed on the display means .
  • the magnitude of the stimulation signal supplied by the pair of stimulation applying electrodes can be adjusted based on the information displayed on the display means. Thereby, more appropriate stimulation can be applied.
  • the sacrum 3 has a sacral foramen 18, which exists in the human body 2 symmetrically.
  • the control of urine storage involves the pelvic visceral nerve 20, the genital nerve 22 and the hypogastric nerve 28 (see FIG. 1). These nerves are connected to the bladder 19 and the urethral sphincter 21.
  • the pelvic visceral nerve 20 leads from the sacral foramen 18 to the bladder 19; the pudendal nerve 22 leads from the sacral foramen 18 to the urethral sphincter 21.
  • the symptoms of urination disorder can be alleviated.
  • the urination disorder treatment device of the present invention can provide stimulation to the pelvic visceral nerve 20 and the pudendal nerve 22 via the pair of stimulation application electrodes 1a and 1b.
  • Treatment by the urination disorder treatment device of the present invention includes alleviation of symptoms of urination disorder.
  • the sciatic nerve 23 passes through the sacral foramen 18 and branches into the peroneal nerve 26 and the tibial nerve 27 in the lower leg. Thereby, the sciatic nerve 23 controls the movement of the distal part of the lower leg.
  • the sciatic nerve 23 has a muscle limb, and the muscle limb derived from the sciatic nerve 23 is connected to each tissue (muscle) of the left leg 5 and the right leg 8 of the human body.
  • the muscle limb derived from the sciatic nerve 23 is connected to the biceps femoris 6 of the left leg 5 and the biceps femoris 9 of the right leg 8 (see FIG. 3); 30 and the semitendinoid muscle 31 of the right leg 8 (see FIG. 4).
  • the muscle limbs derived from the tibial nerve 27 are connected to the gastrocnemius muscle 24 of the left leg 5 and the gastrocnemius muscle 25 of the right leg 8 (see FIG. 5); flat sole muscle 33 of the left leg 5 and flounder of the right leg 8 It is connected to the muscle 34 (see FIG. 6).
  • the urination disorder treatment device of the present invention comprises stimulation transfer detection electrodes 7a and 7b and stimulation for detecting a biosignal generated in response to a stimulation signal supplied by a pair of stimulation application electrodes 1a and 1b.
  • the transmission detection electrodes 10a and 10b are provided (see FIG. 3 and the like).
  • the pair of stimulation transfer detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b only have to be able to detect biosignals generated in response to the stimulation signals supplied by the pair of stimulation applying electrodes 1a and 1b, and the arrangement is particularly limited I will not.
  • the stimulation transfer detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b may be disposed on the skin near the urethral sphincter 21 (see FIG. 1) to which the pudendal nerve 22 is connected or the skin near the perianal muscle .
  • the stimulation transfer detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b are disposed on the skin (rear surface) near the muscle tissue of the lower limb which is a tissue to which the sciatic nerve 23 is connected.
  • the tissue to which the sciatic nerve 23 is connected also means the tissue connected to the nerve branched from the sciatic nerve 23.
  • the nerve branched from the sciatic nerve 23 is, for example, the tibial nerve 27.
  • the sacral foramen 18 has a symmetrical structure, and the sciatic nerve 23 and the tibial nerve 27 also have a symmetrical structure. Therefore, the biosignal generated in response to the stimulation signal to the left sacral foramen is detected by the stimulation transmitting detection electrodes 7a and 7b disposed on the left leg 5; while, it responds to the stimulation signal to the right sacral foramen The biosignal generated may be detected by the stimulation transfer detection electrodes 10a and 10b disposed on the right leg 8.
  • the pair of stimulation transfer detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b are respectively disposed on the skin near the muscle tissue of both limbs, which is a tissue to which the sciatic nerve 23 is connected, the pair of stimulation application electrodes
  • the biosignals generated in response to the respective 1a and 1b stimulation signals are easily detected separately.
  • the stimulation transfer detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b are disposed in the vicinity of the muscles of the left leg 5 and the right leg 8, respectively.
  • the biological signal generated in response to the stimulation signal of each of the pair of stimulation applying electrodes 1a and 1b typically means an evoked potential.
  • Evoked potential refers to a voltage response that is induced in a tissue (for example, muscle tissue) to which a nerve is connected when a certain stimulus is applied to the nerve.
  • the urination disorder treatment device in the first embodiment includes a pair of stimulation application electrodes 1a and 1b, stimulation transmission detection electrodes 7a and 7b, stimulation transmission detection electrodes 10a and 10b, a ground electrode 32, a stimulation signal supply source 4, a measurement unit 15, The control unit 16, the display means 17, and the operation unit 29 are provided (see FIG. 3).
  • the pair of stimulation applying electrodes 1 a and 1 b are disposed on the back of the sacrum 3 of the human body 2 at a predetermined interval and opposed to the center axis of the human body 2 in the left and right direction.
  • the back of the sacrum means "the face of the back near the sacrum”.
  • a stimulation signal source 4 is connected to the pair of stimulation applying electrodes 1a and 1b.
  • the stimulation transfer detection electrodes 7 a and 7 b are disposed on the back of the biceps femoris 6 of the left leg 5; the stimulation transfer detection electrodes 10 a and 10 b are the biceps femoris 9 of the right leg 8. Is located on the back of the.
  • the arrangement interval between the stimulation transfer detection electrodes 7a and 7b and the arrangement interval between the stimulation transfer detection electrodes 10a and 10b are preferably set in the range of about 2 to 3 cm.
  • the “biceps femoris 6” in the present specification and the appended claims includes any of the biceps femoris short head 11 and the biceps femoris long head 12;
  • the “biceps femoris 9” includes any of the biceps femoris short head 13 and the biceps femoris long head 14.
  • a measurement unit 15 is connected to the stimulation transfer detection electrodes 7a and 7b disposed in the biceps femoris 6 and the stimulation transfer detection electrodes 10a and 10b disposed in the biceps femoris 9, respectively.
  • the ground electrode 32 is disposed on an arbitrary skin and connected to the measurement unit 15.
  • the control unit 16 is connected to the measurement unit 15, and the stimulation signal supply source 4, the display unit 17, and the operation unit 29 are connected to the control unit 16.
  • the measurement unit 15 is connected to the stimulation transfer detection electrodes 7a and 7b, the stimulation transfer detection electrodes 10a and 10b, and the ground electrode 32.
  • the ground electrode 32 can be disposed on any skin. However, the preferred arrangement position of the ground electrode 32 is between the pair of stimulus applying electrodes 1a and 1b and the stimulus transfer detecting electrodes 7a and 7b; or the pair of stimulus applying electrodes 1a and 1b and the stimulus transfer detecting electrodes Between 10a and 10b.
  • the ground electrode 32 is preferably disposed at a position not affected by noise due to muscle activity.
  • the ground electrode 32 shown in FIG. 3 is an electrode of one planar shape, but the two ground electrodes may be arranged symmetrically on the left leg 5 and the right leg 8 respectively. Further, the shape of the ground electrode 32 may be a shape in which it is wound around a body or a leg.
  • the pair of stimulation applying electrodes 1a and 1b can apply a bipolar rectangular wave pulse signal to the back of the sacrum 3 as a stimulation signal.
  • a stimulation signal supply source 4 is connected to the pair of stimulation applying electrodes 1a and 1b as a supply source of the pulse signal.
  • the stimulation signal (pulse signal) supplied by the pair of stimulation applied electrodes 1a and 1b alleviates the urination disorder by stimulating the nerve that controls urine storage passing through the urination reflex center present in the sacrum 3.
  • examples of nerves responsible for voiding through the voiding reflex center include the pelvic visceral nerve 20, the pudendal nerve 22 and the inferior abdominal nerve 28, but preferably the pelvic visceral nerve 20 which is a nerve passing near the sacrum It is a pudendal nerve 22.
  • the pulse signal of the bipolar rectangular wave which is a stimulation signal supplied by the pair of stimulation applying electrodes 1a and 1b from the stimulation signal source 4 as a source, has a voltage variable in the range of more than 0 and 80 V or less Can be set to be the maximum value in the range not accompanied by
  • the pulse signal of the bipolar rectangular wave set as such has, for example, a pulse width of 200 ⁇ s, a frequency of 30 Hz, an intermittent timing of 5 seconds ON, 5 seconds OFF, and a current of 0 to 80 mA.
  • the magnitude of the stimulation signal applied by the pair of stimulation applying electrodes 1 a and 1 b using the stimulation signal supply source 4 as a supply source may be adjusted by the control unit 16 in accordance with the operation of the operation unit 29.
  • the size of the stimulation signal can be set to an optimal value by operating the operation unit 29 by the treating person (or the patient himself). That is, the therapist can adjust the bipolar rectangular wave voltage as the stimulation signal applied to the pair of stimulation applying electrodes 1a and 1b within the range of more than 0 and 80 V or less.
  • the urinating disorder treatment device stimulates the nerve that controls urine storage via the pair of stimulation application electrodes 1a and 1b to enhance the urine storage function and prevent urinary incontinence and frequent urination. Do. However, if the pair of stimulation applying electrodes 1a and 1b are not disposed at appropriate positions on the back of the sacrum 3 of the human body 2, the nerve can not be appropriately stimulated, and a sufficient therapeutic effect can not be obtained.
  • the stimulation transfer detection electrodes 7a and 7b to be disposed on the back of the biceps femoris 6 of the left leg 5 and the back of the biceps femoris 9 of the right leg 8 It has stimulation transfer detection electrodes 10a and 10b for placement.
  • the urination disorder treatment device of the first embodiment can measure the potential difference between the stimulation transfer detection electrodes 7a and 7b and the potential difference between the stimulation transfer detection electrodes 10a and 10b.
  • measurement unit 15 measures the potential difference between stimulation transfer detection electrodes 7a and 7b and the potential difference between stimulation transfer detection electrodes 10a and 10b with reference to the potential of ground electrode 32.
  • the measurement unit 15 can measure the muscle action potential of the biceps femoris muscle 6 of the left leg 5 detected by the stimulation transfer detection electrodes 7a and 7b; the stimulation transfer detection electrodes 10a and 10b are The muscle action potential of the biceps femoris 9 of the right leg 8 to be detected can be measured.
  • the pair of stimulation applied electrodes 1a and 1b stimulate nerves
  • the muscle activity of biceps femoris 6 and 9 is induced.
  • the stimulation action detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b detect this induced muscle action potential (referred to as "evoked potential") of the biceps femoris muscle 6 and 9 as a biosignal, and the section is measured.
  • Measuring at 15 is a feature of the urination disorder treatment device of the first embodiment.
  • the evoked potential which is a biological signal, is detected by the stimulation transfer detection electrode about 10 milliseconds to 30 milliseconds after the pair of stimulation applying electrodes 1a and 1b apply the stimulation signal to the back of the sacrum 3.
  • the pair of stimulation applying electrodes 1a and 1b applying appropriate stimulation? It can be determined whether or not the pair of stimulation applying electrodes 1a and 1b can be disposed at the appropriate position on the back of the sacrum 3.
  • the sciatic nerve 23 The stimulation transmission to the biceps femoris 6 of the left leg 5 is not properly performed. Therefore, the biosignal is not detected by the stimulation transfer detection electrodes 7a and 7b, or the biosignal to be detected is reduced.
  • the other electrode 1b of the pair of stimulation application electrodes can not be disposed at an appropriate position on the back of the sacrum 3, even if the electric stimulation is applied to the pair of stimulation application electrodes 1a and 1b, The stimulation transmission to the biceps femoris 6 of the right leg 8 through the nerve 23 is not properly performed. Therefore, the biosignal is not detected by the stimulation transfer detection electrodes 10a and 10b, or the biosignal to be detected is reduced.
  • the biological signal measured by the measurement unit 15 is transmitted to the control unit 16.
  • the control unit 16 displays the measurement result by the measurement unit 15 on the display unit 17.
  • the measurement result displayed on the display means 17 may be the measurement value itself of the biosignal by the measurement unit 15; based on the measurement value, an appropriate stimulus is transmitted to the sacrum or a nerve passing through this sacrum.
  • the pair of stimulation applying electrodes 1a and 1b may be determined as to whether or not they are disposed at appropriate positions on the back surface of the sacrum 3 or not.
  • the determination as to whether or not the appropriate stimulus has been transmitted or whether or not the appropriate arrangement has been made can be made, for example, in the following manner.
  • the lower limit reference value of the size (potential difference) of the biological signal to be measured is set in advance, and control is performed based on whether the measured magnitude (potential difference) of the biological signal exceeds the lower limit reference value
  • the part 16 makes a decision.
  • a time zone (latency time) until the biomedical signal is measured is set in advance, and the control unit 16 is determined based on whether the measured biomedical signal can be measured in the set time zone (latency time) Will judge. It is desirable to set the time period until the biomedical signal is measured from about 10 milliseconds to 30 milliseconds after the stimulation application time (0 milliseconds) to the back of the sacrum 3 by the stimulation application electrode.
  • the control unit 16 when the biological signal detected by the stimulation transfer detection electrodes 7a and 7b disposed on the left leg 5 is measured after an extremely short time or a long time from the set time zone (latency time), the control unit 16 However, the display means 17 displays that the stimulation transmission from the stimulation application electrode 1a is inappropriate, or displays that the arrangement of the stimulation application electrode 1a is inappropriate.
  • the biological signal detected by the stimulation transfer detection electrodes 7a and 7b is measured in the vicinity of the set time zone (latency)
  • the size (potential difference) of the measured biological signal and the set biological signal The lower reference value of the magnitude (potential difference) of
  • the control unit 16 displays on the display means 17 that the stimulation transmission from the stimulation applying electrode 1a is inappropriate, or The display means 17 displays that the arrangement of the stimulation applying electrodes 1a is inappropriate.
  • the control unit 16 indicates that the stimulation transmission from the stimulation applying electrode 1a is appropriate. It is displayed on the display means 17, or displayed on the display means 17 that the arrangement of the stimulation applying electrode 1a is appropriate.
  • the control unit displays on the display means 17 that the stimulation transmission from the stimulation applying electrode 1b is inappropriate, or displays on the display 17 that the arrangement of the stimulation application electrode 1b is inappropriate.
  • the magnitude (potential difference) of the measured biological signal and the magnitude of the set biological signal Compare with the lower reference value of the distance (potential difference).
  • the control unit 16 displays on the display means 17 that the stimulation transmission from the stimulation applying electrode 1b is inappropriate, or The display means 17 displays that the arrangement of the stimulation applying electrode 1b is inappropriate.
  • the control unit 16 indicates that the stimulation transmission from the stimulation applying electrode 1b is appropriate. It is displayed on the display means 17 or displayed on the display means 17 that the arrangement of the stimulation applying electrode 1b is appropriate.
  • the measurement of the signal by the measurement unit 15 may be performed multiple times. That is, the process may include the steps of measuring the biological signals detected by the stimulation transfer detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b a plurality of times and averaging the plurality of measured values. In this case, it is appropriate based on whether the biological signal after the averaging process is measured in the set time zone (latency) or larger than the lower limit reference value of the set size (potential difference) of the biological signal. To determine if the stimulation has been performed or if the stimulation electrode has been properly placed.
  • the biosignal X detected by the stimulation transmission detection electrodes 7a and 7b disposed in the left leg 5, the stimulation transmission detection electrode 10a disposed in the right leg 8, and You may compare with the biological signal Y which 10b detects. That is, the time until the biosignal X is detected (latency) and the time until the biosignal Y is detected (latency) are compared; or the magnitude (potential difference) of the biosignal X and the biosignal The magnitude (potential difference) of Y may be compared.
  • the arrangement of the pair of stimulus applying electrodes 1a and 1b is adjusted so that the difference in latency or potential is reduced. Thereby, the therapeutic effect can be enhanced by setting the pair of stimulation applying electrodes 1a and 1b in a more appropriate arrangement relationship.
  • control unit 16 can adjust the magnitude of the stimulation signal applied by the pair of stimulation applying electrodes 1a and 1b according to the operation of the operation unit 29.
  • the biological signals detected by the stimulation transfer detection electrodes 7a and 7b and the biological signals detected by the stimulation transmission detection electrodes 10a and 10b become values larger than the set lower limit reference value.
  • Adjustment of the magnitude of the stimulation signal is tailored to the individual patient. The reason is that the magnitude of the stimulus signal suitable for obtaining a therapeutic effect to alleviate urination disorder varies from patient to patient. Therefore, it is preferable to adjust the magnitude of the bipolar rectangular wave pulse signal applied by the pair of stimulus applying electrodes 1a and 1b while confirming the treatment effect of the individual patient.
  • the user can confirm whether the appropriate stimulation can be transmitted or not by the information displayed on the display means 17. That is, treatment can be performed while realizing the therapeutic effect of the stimulation given via the pair of stimulation applying electrodes 1a and 1b.
  • FIG. 4 shows the urination disorder treatment device in the second embodiment of the present invention.
  • the stimulation transfer detection electrode of the urination disorder treatment device of the second embodiment is disposed on the back of the semitendinoid muscles 30 and 31 present inside the biceps femoris 6 and 9 (see FIG. 3). That is, the stimulation transfer detection electrodes 7a and 7b are disposed on the back of the semitendinoid muscle 30 of the left leg 5; and the stimulation transmission detection electrodes 10a and 10b are disposed on the back of the semitendinoid muscle 31 of the right leg 8. ing.
  • the sciatic nerve 23 passes through the sacral foramen 18. Then, as shown in FIG. 4, the muscle limb derived from the sciatic nerve 23 is connected to the semitendinoid muscle 30 of the lower left leg 5 and the semitendinoid muscle 31 of the right leg 8.
  • measuring the biological signal includes measuring the latency and the magnitude (potential difference) of the biological signal.
  • FIG. 5 shows the urination disorder treatment device in the third embodiment of the present invention.
  • the stimulation transfer detection electrodes of the urination disorder treatment device of the third embodiment are present in the distal portion of the lower extremity than the biceps femoris 6 and 9 (see FIG. 3) and the semitendinoid muscles 30 and 31 (see FIG. 4).
  • the sciatic nerve 23 passes through the sacral foramen 18. Then, as shown in FIG. 5, the sciatic nerve 23 branches downward to the common peroneal nerve 26 and the tibial nerve 27. Muscle branches of the tibial nerve 27 are connected to the gastrocnemius muscles 24 and 25, respectively.
  • measuring the biological signal includes measuring the latency and the magnitude (potential difference) of the biological signal.
  • FIG. 6 shows the urination disorder treatment device in the fourth embodiment of the present invention.
  • the stimulation transmitting detection electrodes of the urination disorder treatment device of the fourth embodiment are disposed on the back of soleus muscles 33 and 34 which are more on the back outside than the gastrocnemius muscles 24 and 25 (see FIG. 5). That is, the stimulation transfer detection electrodes 7a and 7b are disposed on the back of the flatfish muscle 33 of the left leg 5, and the stimulation transmission detection electrodes 10a and 10b are disposed on the back of the flatfish muscle 34 of the right leg 8.
  • the sciatic nerve 23 passes through the sacral foramen 18. And, as shown in FIG. 6, the sciatic nerve 23 branches downward to the common peroneal nerve 26 and the tibial nerve 27. The branches of the tibial nerve 27 are connected to the soleus muscles 33 and 34 respectively.
  • the biomedical signals detected by the stimulation transfer detection electrodes 7a and 7b disposed on the back of the flatfish muscle 33 of the left leg 5 and the stimulation transfer detection electrodes 10a and 10b disposed on the back of the flatfish muscle 34 of the right leg 8 are By measuring, it is possible to determine whether the arrangement of the pair of stimulus applying electrodes 1a and 1b is appropriate.
  • measuring the biological signal includes measuring the latency and the magnitude (potential difference) of the biological signal.
  • the urinating disorder treatment device stimulates the nerve that controls urination passing through the urination reflex center of the sacral region via at least a pair of stimulation application electrodes arranged at a predetermined interval on the back side of the sacrum. Treat the urination disorder by transmitting a signal.
  • the urination disorder treatment device of the present invention has a stimulation transfer detection electrode, and can detect a biosignal generated in response to the stimulation signal. By measuring the biological signal, it can be displayed on the display means whether the appropriate biological signal is given. While confirming the display, the therapist can appropriately adjust the arrangement position of the pair of stimulation electrodes so as to give an appropriate stimulation signal. It realizes appropriate treatment.
  • the urinating disorder treatment device of the present invention has an operation unit for adjusting the strength of the stimulation signal; the treatment person can give the appropriate stimulation signal while confirming the display. To adjust the strength of the stimulation signal to give the patient appropriate stimulation.
  • the urination disorder treatment device of the present invention can realize more effective urination disorder treatment.

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Abstract

Disclosed is a treatment device for urination disorders, said treatment device being capable of determining whether or not stimulation-applying electrodes are appropriately arranged and whether or not nerves that control urine accumulation and urination are being appropriately stimulated. The disclosed treatment device can therefore provide appropriate treatment for urination disorders. The treatment device is provided with: at least one pair of stimulation-applying electrodes that apply a stimulation signal to the dorsal surface of the sacrum; a stimulation-signal source that supplies the stimulation signal applied by the stimulation-applying electrodes; a stimulation-transmission detection electrode that is disposed near tissue connected to nerves that run near the sacrum or to the sacrum, and that detects a biosignal that arises in response to the stimulation signal; a ground electrode; a measurement unit that measures the biosignal detected by the stimulation-transmission detection electrode; a control unit that controls the application of the stimulation signal by the pair of stimulation-applying electrodes; and a display means that displays the measurement result from the measurement unit.

Description

排尿障害治療器Treatment for urination disorder
　本発明は、排尿障害を治療する排尿障害治療器に関する。 The present invention relates to a urination disorder treatment device for treating urination disorder.
　従来の排尿障害治療器は、仙骨背面に所定間隔をおいて配置された一対の刺激印加電極が、刺激信号供給源からの刺激信号を供給する構成を有する。前記刺激信号により、仙骨部排尿反射中枢を通る蓄排尿を司る神経を介して膀胱及び尿道部分を刺激し、排尿障害を緩和させていた。 The conventional urination disorder treatment device has a configuration in which a pair of stimulation electrodes arranged at a predetermined distance on the dorsal surface of the sacrum supply a stimulation signal from a stimulation signal source. According to the stimulation signal, the bladder and the urethral portion are stimulated via the nerve responsible for urine collection passing through the sacral urination reflex center to alleviate urination disorder.
特公平３－２６６２３号公報Japanese Examined Patent Publication 3-26623
　ところが従来の排尿障害治療器には、適切な治療を行うことが難しい場合があった。すなわち、仙骨部の排尿反射中枢を通る蓄排尿をつかさどる神経へ刺激を伝えるには、一対の刺激印加電極を仙骨背面の適切な部分に配置しなければならない。一対の刺激印加電極を適切な位置に配置しないと、膀胱及び尿道部分へ適切な刺激を加えることができないためである。ところが、従来の排尿障害治療器では、刺激印加電極を適切な位置に配置できているか否かを判断することができず、適切な治療が行えないことがあった。 However, there are cases where it is difficult to perform appropriate treatment in a conventional urination disorder treatment device. That is, in order to transmit stimulation to the nerve responsible for urine storage passing through the urination reflex center of the sacral region, a pair of stimulation application electrodes must be disposed at an appropriate part of the sacral dorsal surface. This is because if the pair of stimulus applying electrodes are not properly positioned, it is not possible to apply an appropriate stimulus to the bladder and the urethra part. However, in the conventional urination disorder treatment device, it may not be possible to determine whether or not the stimulation application electrode can be disposed at an appropriate position, and an appropriate treatment may not be performed.
　そこで本発明は、刺激印加電極が適切に配置されているかどうか、および蓄排尿をつかさどる神経に適切な刺激を加えているかどうかを判断できるようにすることで、排尿障害の適切な治療が行える排尿障害治療器を提供することを目的とする。 Therefore, the present invention is capable of performing appropriate treatment of urination disorder by making it possible to determine whether the stimulus applying electrode is properly disposed and whether or not the nerve that controls urine storage is applying the appropriate stimulus. It aims to provide a disorder treatment device.
　上記目的を達成するために、本発明の排尿障害治療器は以下の構成を有する。
　１）患者の仙骨背面に所定間隔を介して配置され、仙骨背面に刺激信号を供給する少なくとも一対の刺激印加電極；
　２）前記一対の刺激印加電極が刺激信号を供給するための刺激信号供給源；
　３）前記仙骨または前記仙骨近傍を通る神経がつながっている組織付近に配置され、前記刺激信号に応答して発生する生体信号を検出する刺激伝達検出電極；
　４）前記患者の任意の皮膚上に配置される接地電極；
　５）前記刺激伝達検出電極と前記接地電極とに接続され、前記刺激伝達検出電極が検出する生体信号を測定する測定部；
　６）前記測定部に接続され、測定部の測定結果に基づき前記一対の刺激印加電極による前記刺激信号の供給を制御する制御部；
　７）前記制御部に接続され、前記測定部による測定結果を表示される表示手段。 In order to achieve the above object, the urination disorder treatment device of the present invention has the following configuration.
1) At least one pair of stimulation electrodes arranged on the back of the patient's sacrum via a predetermined interval and supplying stimulation signals to the back of the sacrum;
2) a stimulation signal source for the pair of stimulation electrodes to supply a stimulation signal;
3) a stimulation transmitting detection electrode which is disposed in the vicinity of a tissue connected by a nerve passing through the sacrum or the vicinity of the sacrum, and detecting a biosignal generated in response to the stimulation signal;
4) a ground electrode placed on any skin of the patient;
5) a measurement unit connected to the stimulation transfer detection electrode and the ground electrode and measuring a biological signal detected by the stimulation transfer detection electrode;
6) A control unit connected to the measurement unit and controlling supply of the stimulation signal by the pair of stimulation application electrodes based on the measurement result of the measurement unit;
7) Display means connected to the control unit and displaying the measurement result by the measurement unit.
　本発明の排尿障害治療器によれば、仙骨部の排尿反射中枢を通る蓄排尿をつかさどる神経に、一対の刺激印加電極が適切な刺激を伝達しているか否か、を判断することができる。具体的には、刺激伝達検出電極と測定部とで、仙骨背面刺激に対する生体信号を測定することにより、適切な刺激がなされているかどうかを確認することができる。そのため、効果的な治療が実現される。 According to the urinating disorder treatment device of the present invention, it can be determined whether or not a pair of stimulation applying electrodes transmit an appropriate stimulus to the nerve responsible for urination passing through the urination reflex center of the sacral region. Specifically, by measuring the biosignal to the sacral dorsal stimulation with the stimulation transfer detection electrode and the measurement unit, it is possible to confirm whether or not the appropriate stimulation is performed. Therefore, effective treatment is realized.
　つまり、本発明の排尿障害治療器によれば、一対の刺激印加電極が蓄排尿をつかさどる神経に適切な刺激が伝達されているか否かを、表示手段に表示された情報から判断することができる。治療者（患者自身であってもよい）は、表示手段に表示された情報に基づいて、一対の刺激印加電極の配置位置を適切な位置に修正することで、適切な刺激を加えることができる。 That is, according to the urinating disorder treatment device of the present invention, it can be judged from the information displayed on the display means whether or not the appropriate stimulus is transmitted to the nerves in which the pair of stimulus application electrodes manage urine storage. . The therapist (which may be the patient himself) can apply an appropriate stimulus by correcting the arrangement position of the pair of stimulus applying electrodes to an appropriate position based on the information displayed on the display means .
　また、本発明の排尿障害治療器によれば、表示手段に表示された情報に基づいて、一対の刺激印加電極が供給する刺激信号の大きさを調整することができる。それにより、より適切な刺激を加えることができる。 Further, according to the urination disorder treatment apparatus of the present invention, the magnitude of the stimulation signal supplied by the pair of stimulation applying electrodes can be adjusted based on the information displayed on the display means. Thereby, more appropriate stimulation can be applied.
排尿障害治療器を適用する人体の側断面図Side cross-sectional view of the human body to which urination disorder treatment equipment is applied 排尿障害治療器を適用する人体の背面図Rear view of human body applying urination disorder treatment device 本発明の実施の形態１にかかる排尿障害治療器のブロック図Block diagram of the urination disorder treatment device according to the first embodiment of the present invention 本発明の実施の形態２にかかる排尿障害治療器のブロック図Block diagram of the urination disorder treatment device according to the second embodiment of the present invention 本発明の実施の形態３にかかる排尿障害治療器のブロック図Block diagram of the urination disorder treatment device according to the third embodiment of the present invention 本発明の実施の形態４にかかる排尿障害治療器のブロック図Block diagram of the urination disorder treatment device according to the fourth embodiment of the present invention
　まず、本発明の排尿障害治療器による排尿障害の治療メカニズムの概要を説明する。 First, an outline of a treatment mechanism of urination disorder by the urination disorder treatment device of the present invention will be described.
　図１および図２は、人体２の仙骨３の近傍部分を示す。仙骨３は、仙骨孔１８を有し、仙骨孔１８は左右対称に人体２に存在する。蓄排尿の制御には、骨盤内臓神経２０、陰部神経２２および下腹神経２８が関与している（図１参照）。これらの神経は、膀胱１９および尿道括約筋２１につながっているからである。 1 and 2 show the vicinity of the sacrum 3 of the human body 2. The sacrum 3 has a sacral foramen 18, which exists in the human body 2 symmetrically. The control of urine storage involves the pelvic visceral nerve 20, the genital nerve 22 and the hypogastric nerve 28 (see FIG. 1). These nerves are connected to the bladder 19 and the urethral sphincter 21.
　骨盤内臓神経２０は仙骨孔１８から膀胱１９にまでつながっており；陰部神経２２は仙骨孔１８から尿道括約筋２１にまでつながっている。これらの骨盤内臓神経２０および陰部神経２２に刺激を与えることで、排尿障害の症状を緩和させることができる。 The pelvic visceral nerve 20 leads from the sacral foramen 18 to the bladder 19; the pudendal nerve 22 leads from the sacral foramen 18 to the urethral sphincter 21. By stimulating the pelvic visceral nerve 20 and the pudendal nerve 22, the symptoms of urination disorder can be alleviated.
　後述するように、本発明の排尿障害治療器は、一対の刺激印加電極１ａと１ｂを介して骨盤内臓神経２０および陰部神経２２に刺激を与えることができる。本発明の排尿障害治療器による「治療」には、排尿障害の症状を緩和させることを含む。 As described later, the urination disorder treatment device of the present invention can provide stimulation to the pelvic visceral nerve 20 and the pudendal nerve 22 via the pair of stimulation application electrodes 1a and 1b. "Treatment" by the urination disorder treatment device of the present invention includes alleviation of symptoms of urination disorder.
　また、図１および図２に示すように、坐骨神経２３は仙骨孔１８を通っており、下肢において総腓骨神経２６と頸骨神経２７とに分岐する。これにより、坐骨神経２３は、下肢遠位部の動きをつかさどる。 Also, as shown in FIGS. 1 and 2, the sciatic nerve 23 passes through the sacral foramen 18 and branches into the peroneal nerve 26 and the tibial nerve 27 in the lower leg. Thereby, the sciatic nerve 23 controls the movement of the distal part of the lower leg.
　坐骨神経２３は筋肢を有し、坐骨神経２３由来の筋肢は、人体の左脚５および右脚８の各組織（筋肉）につながっている。例えば、坐骨神経２３由来の筋肢は、左脚５の大腿二頭筋６と、右脚８の大腿二頭筋９とにつながっており（図３参照）；左脚５の半腱様筋３０と、右脚８の半腱様筋３１とにつながっている（図４参照）。また、頸骨神経２７由来の筋肢は、左脚５の腓腹筋２４と、右脚８の腓腹筋２５とにつながっており（図５参照）；左脚５のヒラメ筋３３と、右脚８のヒラメ筋３４とにつながっている（図６参照）。 The sciatic nerve 23 has a muscle limb, and the muscle limb derived from the sciatic nerve 23 is connected to each tissue (muscle) of the left leg 5 and the right leg 8 of the human body. For example, the muscle limb derived from the sciatic nerve 23 is connected to the biceps femoris 6 of the left leg 5 and the biceps femoris 9 of the right leg 8 (see FIG. 3); 30 and the semitendinoid muscle 31 of the right leg 8 (see FIG. 4). In addition, the muscle limbs derived from the tibial nerve 27 are connected to the gastrocnemius muscle 24 of the left leg 5 and the gastrocnemius muscle 25 of the right leg 8 (see FIG. 5); flat sole muscle 33 of the left leg 5 and flounder of the right leg 8 It is connected to the muscle 34 (see FIG. 6).
　後述するように、本発明の排尿障害治療器は、一対の刺激印加電極１ａと１ｂが供給した刺激信号に応答して発生する生体信号を検出するための、刺激伝達検出電極７ａと７ｂおよび刺激伝達検出電極１０ａと１０ｂを有する（図３などを参照）。 As will be described later, the urination disorder treatment device of the present invention comprises stimulation transfer detection electrodes 7a and 7b and stimulation for detecting a biosignal generated in response to a stimulation signal supplied by a pair of stimulation application electrodes 1a and 1b. The transmission detection electrodes 10a and 10b are provided (see FIG. 3 and the like).
　一対の刺激伝達検出電極７ａと７ｂおよび刺激伝達検出電極１０ａと１０ｂは、一対の刺激印加電極１ａと１ｂが供給した刺激信号に応答して発生する生体信号を検出できればよく、その配置は特に限定されない。例えば、刺激伝達検出電極７ａと７ｂおよび刺激伝達検出電極１０ａと１０ｂは、陰部神経２２がつながっている尿道括約筋２１（図１参照）近傍の皮膚や会陰筋近傍の皮膚に配置されてもよい。 The pair of stimulation transfer detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b only have to be able to detect biosignals generated in response to the stimulation signals supplied by the pair of stimulation applying electrodes 1a and 1b, and the arrangement is particularly limited I will not. For example, the stimulation transfer detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b may be disposed on the skin near the urethral sphincter 21 (see FIG. 1) to which the pudendal nerve 22 is connected or the skin near the perianal muscle .
　ただし好ましくは、刺激伝達検出電極７ａと７ｂおよび刺激伝達検出電極１０ａと１０ｂは、坐骨神経２３がつながっている組織である下肢の筋肉組織付近の皮膚（背面）に配置される。坐骨神経２３がつながっている組織とは、坐骨神経２３から分岐した神経とつながっている組織をも意味する。坐骨神経２３から分岐した神経とは、例えば頸骨神経２７である。 However, preferably, the stimulation transfer detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b are disposed on the skin (rear surface) near the muscle tissue of the lower limb which is a tissue to which the sciatic nerve 23 is connected. The tissue to which the sciatic nerve 23 is connected also means the tissue connected to the nerve branched from the sciatic nerve 23. The nerve branched from the sciatic nerve 23 is, for example, the tibial nerve 27.
　図１～図６に示されるように、仙骨孔１８は左右対称の構造を有しており、かつ坐骨神経２３や頸骨神経２７も、左右対称の構造を有している。そのため、左側の仙骨孔への刺激信号に応答して発生する生体信号は、左脚５に配置した刺激伝達検出電極７ａと７ｂによって検出され；一方、右側の仙骨孔への刺激信号に応答して発生する生体信号は、右脚８に配置した刺激伝達検出電極１０ａと１０ｂによって検出されうる。 As shown in FIGS. 1 to 6, the sacral foramen 18 has a symmetrical structure, and the sciatic nerve 23 and the tibial nerve 27 also have a symmetrical structure. Therefore, the biosignal generated in response to the stimulation signal to the left sacral foramen is detected by the stimulation transmitting detection electrodes 7a and 7b disposed on the left leg 5; while, it responds to the stimulation signal to the right sacral foramen The biosignal generated may be detected by the stimulation transfer detection electrodes 10a and 10b disposed on the right leg 8.
　つまり、一対の刺激伝達検出電極７ａと７ｂおよび刺激伝達検出電極１０ａと１０ｂをそれぞれ、坐骨神経２３がつながっている組織である両肢の筋肉組織付近の皮膚に配置すれば、一対の刺激印加電極１ａと１ｂそれぞれの刺激信号に応答して発生する生体信号を、別個に検出しやすい。その結果、後述の通り、一対の刺激印加電極１ａと１ｂのそれぞれについて、適切に配置されているかどうかを判断しやすい。 That is, if the pair of stimulation transfer detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b are respectively disposed on the skin near the muscle tissue of both limbs, which is a tissue to which the sciatic nerve 23 is connected, the pair of stimulation application electrodes The biosignals generated in response to the respective 1a and 1b stimulation signals are easily detected separately. As a result, as described later, it is easy to determine whether or not each of the pair of stimulation applying electrodes 1a and 1b is appropriately disposed.
　上記理由から、刺激伝達検出電極７ａと７ｂおよび刺激伝達検出電極１０ａと１０ｂは、それぞれ左脚５および右脚８の筋肉の近傍に配置することが好ましい。 For the above reasons, it is preferable to dispose the stimulation transfer detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b in the vicinity of the muscles of the left leg 5 and the right leg 8, respectively.
　一対の刺激印加電極１ａと１ｂそれぞれの刺激信号に応答して発生する生体信号とは、典型的には、誘発電位を意味する。誘発電位とは、一定の刺激を神経に加えたときに、その神経がつながっている組織（例えば筋肉組織）に誘発される電位反応をいう。 The biological signal generated in response to the stimulation signal of each of the pair of stimulation applying electrodes 1a and 1b typically means an evoked potential. Evoked potential refers to a voltage response that is induced in a tissue (for example, muscle tissue) to which a nerve is connected when a certain stimulus is applied to the nerve.
　以下、本発明の実施形態の例を説明する。以下の実施の形態１～４では、坐骨神経２３がつながっている下肢の筋肉組織付近に、刺激伝達検出電極７ａと７ｂおよび刺激伝達検出電極１０ａと１０ｂを配置した形態を、添付図面を参照して説明する。 Hereinafter, examples of embodiments of the present invention will be described. In the following first to fourth embodiments, a configuration in which the stimulation transfer detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b are arranged in the vicinity of the muscle tissue of the lower leg to which the sciatic nerve 23 is connected will be described with reference to the attached drawings. Explain.
　[実施の形態１]
　実施の形態１における排尿障害治療器は、一対の刺激印加電極１ａと１ｂ、刺激伝達検出電極７ａと７ｂ、刺激伝達検出電極１０ａと１０ｂ、接地電極３２、刺激信号供給源４、測定部１５、制御部１６、表示手段１７および操作部２９を具備する（図３参照）。 First Embodiment
The urination disorder treatment device in the first embodiment includes a pair of stimulation application electrodes 1a and 1b, stimulation transmission detection electrodes 7a and 7b, stimulation transmission detection electrodes 10a and 10b, a ground electrode 32, a stimulation signal supply source 4, a measurement unit 15, The control unit 16, the display means 17, and the operation unit 29 are provided (see FIG. 3).
　図３に示されるように、一対の刺激印加電極１ａと１ｂは、人体２の仙骨３の背面に所定間隔をおいて、人体２の中心軸に対して左右に対向して配置されている。仙骨の背面とは、「仙骨近傍の背中の面」を意味する。一対の刺激印加電極１ａと１ｂには、刺激信号供給源４が接続されている。 As shown in FIG. 3, the pair of stimulation applying electrodes 1 a and 1 b are disposed on the back of the sacrum 3 of the human body 2 at a predetermined interval and opposed to the center axis of the human body 2 in the left and right direction. The back of the sacrum means "the face of the back near the sacrum". A stimulation signal source 4 is connected to the pair of stimulation applying electrodes 1a and 1b.
　図３に示されるように、刺激伝達検出電極７ａと７ｂは、左脚５の大腿二頭筋６の背面に配置され；刺激伝達検出電極１０ａと１０ｂは、右脚８の大腿二頭筋９の背面に配置されている。刺激伝達検出電極７ａと７ｂとの配置間隔、および刺激伝達検出電極１０ａと１０ｂとの配置間隔は、それぞれ約２～３ｃｍの範囲内に設定されることが望ましい。 As shown in FIG. 3, the stimulation transfer detection electrodes 7 a and 7 b are disposed on the back of the biceps femoris 6 of the left leg 5; the stimulation transfer detection electrodes 10 a and 10 b are the biceps femoris 9 of the right leg 8. Is located on the back of the. The arrangement interval between the stimulation transfer detection electrodes 7a and 7b and the arrangement interval between the stimulation transfer detection electrodes 10a and 10b are preferably set in the range of about 2 to 3 cm.
　本明細書および添付の特許請求の範囲における「大腿二頭筋６」とは、大腿二頭筋短頭１１および大腿二頭筋長頭１２のいずれの意味をも含んでおり；同様に、「大腿二頭筋９」とは、大腿二頭筋短頭１３と大腿二頭筋長頭１４のいずれの意味をも含んでいる。 The “biceps femoris 6” in the present specification and the appended claims includes any of the biceps femoris short head 11 and the biceps femoris long head 12; The “biceps femoris 9” includes any of the biceps femoris short head 13 and the biceps femoris long head 14.
　大腿二頭筋６に配置した刺激伝達検出電極７ａと７ｂ、および大腿二頭筋９に配置した刺激伝達検出電極１０ａと１０ｂには、それぞれ測定部１５が接続されている。 A measurement unit 15 is connected to the stimulation transfer detection electrodes 7a and 7b disposed in the biceps femoris 6 and the stimulation transfer detection electrodes 10a and 10b disposed in the biceps femoris 9, respectively.
　また、接地電極３２は、任意の皮膚上に配置されており、測定部１５に接続されている。測定部１５には制御部１６が接続され、さらに制御部１６には刺激信号供給源４と表示手段１７と操作部２９とが接続されている。また、測定部１５は、刺激伝達検出電極７ａと７ｂ、刺激伝達検出電極１０ａと１０ｂおよび接地電極３２に接続されている。 The ground electrode 32 is disposed on an arbitrary skin and connected to the measurement unit 15. The control unit 16 is connected to the measurement unit 15, and the stimulation signal supply source 4, the display unit 17, and the operation unit 29 are connected to the control unit 16. The measurement unit 15 is connected to the stimulation transfer detection electrodes 7a and 7b, the stimulation transfer detection electrodes 10a and 10b, and the ground electrode 32.
　接地電極３２は、任意の皮膚上に配置されうる。ただし、接地電極３２の好ましい配置位置は、一対の刺激印加電極１ａおよび１ｂと、刺激伝達検出電極７ａおよび７ｂとの間であるか；または一対の刺激印加電極１ａおよび１ｂと、刺激伝達検出電極１０ａおよび１０ｂとの間である。 The ground electrode 32 can be disposed on any skin. However, the preferred arrangement position of the ground electrode 32 is between the pair of stimulus applying electrodes 1a and 1b and the stimulus transfer detecting electrodes 7a and 7b; or the pair of stimulus applying electrodes 1a and 1b and the stimulus transfer detecting electrodes Between 10a and 10b.
　また、接地電極３２は、筋活動によるノイズの影響を受けない位置に配置されることが好ましい。図３に示される接地電極３２は、１つの平面形状の電極であるが、２つの接地電極のそれぞれを、左脚５と右脚８に左右対称に配置してもよい。また、接地電極３２の形状を胴体や脚部に巻きつける形状にしてもよい。 Further, the ground electrode 32 is preferably disposed at a position not affected by noise due to muscle activity. The ground electrode 32 shown in FIG. 3 is an electrode of one planar shape, but the two ground electrodes may be arranged symmetrically on the left leg 5 and the right leg 8 respectively. Further, the shape of the ground electrode 32 may be a shape in which it is wound around a body or a leg.
　一対の刺激印加電極１ａと１ｂは、刺激信号として双極性矩形波のパルス信号を仙骨３背面に印加することができる。そのパルス信号の供給源として、一対の刺激印加電極１ａと１ｂには刺激信号供給源４が接続している。一対の刺激印加電極１ａと１ｂにより供給される刺激信号（パルス信号）が、仙骨３に存在する排尿反射中枢を通る蓄排尿をつかさどる神経を刺激することで、排尿障害を緩和させる。前述の通り、排尿反射中枢を通る蓄排尿をつかさどる神経の例には、骨盤内臓神経２０、陰部神経２２および下腹神経２８が含まれるが、好ましくは仙骨近傍を通る神経である骨盤内臓神経２０および陰部神経２２である。 The pair of stimulation applying electrodes 1a and 1b can apply a bipolar rectangular wave pulse signal to the back of the sacrum 3 as a stimulation signal. A stimulation signal supply source 4 is connected to the pair of stimulation applying electrodes 1a and 1b as a supply source of the pulse signal. The stimulation signal (pulse signal) supplied by the pair of stimulation applied electrodes 1a and 1b alleviates the urination disorder by stimulating the nerve that controls urine storage passing through the urination reflex center present in the sacrum 3. As mentioned above, examples of nerves responsible for voiding through the voiding reflex center include the pelvic visceral nerve 20, the pudendal nerve 22 and the inferior abdominal nerve 28, but preferably the pelvic visceral nerve 20 which is a nerve passing near the sacrum It is a pudendal nerve 22.
　刺激信号供給源４を供給源として、一対の刺激印加電極１ａと１ｂが供給する刺激信号である双極性矩形波のパルス信号は、電圧が０超８０Ｖ以下の範囲で可変であり、患者が痛みを伴わない範囲で最大の値となるように設定されうる。そのように設定された双極性矩形波のパルス信号は、例えば、パルス幅が２００μ秒、周波数が３０Ｈｚ、間欠タイミングがＯＮ５秒、ＯＦＦ５秒、電流は０～８０ｍＡである。 The pulse signal of the bipolar rectangular wave, which is a stimulation signal supplied by the pair of stimulation applying electrodes 1a and 1b from the stimulation signal source 4 as a source, has a voltage variable in the range of more than 0 and 80 V or less Can be set to be the maximum value in the range not accompanied by The pulse signal of the bipolar rectangular wave set as such has, for example, a pulse width of 200 μs, a frequency of 30 Hz, an intermittent timing of 5 seconds ON, 5 seconds OFF, and a current of 0 to 80 mA.
　刺激信号供給源４を供給源として、一対の刺激印加電極１ａと１ｂが印加する刺激信号の大きさは、操作部２９での操作に応じて制御部１６によって調整されてもよい。また、治療者（患者自身であってもよい）が操作部２９を操作して、刺激信号の大きさを最適値に設定することもできる。つまり治療者は、一対の刺激印加電極１ａと１ｂに印加される刺激信号としての双極性の矩形波電圧を、０超８０Ｖ以下の範囲内で調整することができる。 The magnitude of the stimulation signal applied by the pair of stimulation applying electrodes 1 a and 1 b using the stimulation signal supply source 4 as a supply source may be adjusted by the control unit 16 in accordance with the operation of the operation unit 29. Also, the size of the stimulation signal can be set to an optimal value by operating the operation unit 29 by the treating person (or the patient himself). That is, the therapist can adjust the bipolar rectangular wave voltage as the stimulation signal applied to the pair of stimulation applying electrodes 1a and 1b within the range of more than 0 and 80 V or less.
　このように、実施の形態１の排尿障害治療器は、一対の刺激印加電極１ａと１ｂを介して蓄排尿をつかさどる神経を刺激することで、蓄尿機能を亢進させ、尿失禁や頻尿を防止する。ところが、一対の刺激印加電極１ａと１ｂが、人体２の仙骨３背面の適切な位置に配置されていないと、適切に神経を刺激できないため、十分な治療効果が得られない。 As described above, the urinating disorder treatment device according to the first embodiment stimulates the nerve that controls urine storage via the pair of stimulation application electrodes 1a and 1b to enhance the urine storage function and prevent urinary incontinence and frequent urination. Do. However, if the pair of stimulation applying electrodes 1a and 1b are not disposed at appropriate positions on the back of the sacrum 3 of the human body 2, the nerve can not be appropriately stimulated, and a sufficient therapeutic effect can not be obtained.
　そこで、実施の形態１の排尿障害治療器は、左脚５の大腿二頭筋６の背面に配置するための刺激伝達検出電極７ａと７ｂと、右脚８の大腿二頭筋９の背面に配置するための刺激伝達検出電極１０ａと１０ｂとを有する。 Therefore, in the urination disorder treatment device of the first embodiment, the stimulation transfer detection electrodes 7a and 7b to be disposed on the back of the biceps femoris 6 of the left leg 5 and the back of the biceps femoris 9 of the right leg 8 It has stimulation transfer detection electrodes 10a and 10b for placement.
　実施の形態１の排尿障害治療器は、刺激伝達検出電極７ａと７ｂとの間の電位差および刺激伝達検出電極１０ａと１０ｂとの間の電位差を測定することができる。具体的には、測定部１５が、接地電極３２の電位を基準として刺激伝達検出電極７ａと７ｂとの間の電位差および刺激伝達検出電極１０ａと１０ｂとの間の電位差を測定する。別の言い方をすると、測定部１５は、刺激伝達検出電極７ａと７ｂが検出する、左脚５の大腿二頭筋６の筋活動電位を測定することができ；刺激伝達検出電極１０ａと１０ｂが検出する、右脚８の大腿二頭筋９の筋活動電位を測定することができる。 The urination disorder treatment device of the first embodiment can measure the potential difference between the stimulation transfer detection electrodes 7a and 7b and the potential difference between the stimulation transfer detection electrodes 10a and 10b. Specifically, measurement unit 15 measures the potential difference between stimulation transfer detection electrodes 7a and 7b and the potential difference between stimulation transfer detection electrodes 10a and 10b with reference to the potential of ground electrode 32. In other words, the measurement unit 15 can measure the muscle action potential of the biceps femoris muscle 6 of the left leg 5 detected by the stimulation transfer detection electrodes 7a and 7b; the stimulation transfer detection electrodes 10a and 10b are The muscle action potential of the biceps femoris 9 of the right leg 8 to be detected can be measured.
　一方、一対の刺激印加電極１ａと１ｂが神経を刺激すると、大腿二頭筋６および９の筋活動が誘発される。この誘発された大腿二頭筋６および９の筋活動電位（「誘発電位」という）を、刺激伝達検出電極７ａと７ｂおよび刺激伝達検出電極１０ａと１０ｂによって生体信号として検出し、それを測定部１５で測定することが、実施の形態１の排尿障害治療器の特徴である。 On the other hand, when the pair of stimulation applied electrodes 1a and 1b stimulate nerves, the muscle activity of biceps femoris 6 and 9 is induced. The stimulation action detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b detect this induced muscle action potential (referred to as "evoked potential") of the biceps femoris muscle 6 and 9 as a biosignal, and the section is measured. Measuring at 15 is a feature of the urination disorder treatment device of the first embodiment.
　生体信号である誘発電位は、一対の刺激印加電極１ａと１ｂが仙骨３背面に刺激信号を印加した時点から、約１０ミリ秒～３０ミリ秒経過後に、刺激伝達検出電極によって検出される。 The evoked potential, which is a biological signal, is detected by the stimulation transfer detection electrode about 10 milliseconds to 30 milliseconds after the pair of stimulation applying electrodes 1a and 1b apply the stimulation signal to the back of the sacrum 3.
　このようにして、刺激伝達検出電極７ａと７ｂおよび刺激伝達検出電極１０ａと１０ｂにより検出される電位（誘発電位）に基づいて、一対の刺激印加電極１ａと１ｂが適切な刺激を印加しているか否かを判断する、すなわち一対の刺激印加電極１ａと１ｂが、仙骨３背面の適切な位置に配置できているか否かを判断することができる。 In this way, based on the potentials (evoked potentials) detected by the stimulation transfer detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b, are the pair of stimulation applying electrodes 1a and 1b applying appropriate stimulation? It can be determined whether or not the pair of stimulation applying electrodes 1a and 1b can be disposed at the appropriate position on the back of the sacrum 3.
　一対の刺激印加電極のうちの一方の電極１ａを仙骨３背面の適切な位置に配置できていない場合には、一対の刺激印加電極１ａと１ｂが刺激信号を印加しても、坐骨神経２３を介する左脚５の大腿二頭筋６への刺激伝達が適切に行われない。そのため、刺激伝達検出電極７ａと７ｂによって生体信号が検出されないか、または検出される生体信号が小さくなる。 If one of the pair of stimulation application electrodes 1a can not be placed at an appropriate position on the back of the sacrum 3, even if the pair of stimulation application electrodes 1a and 1b apply a stimulation signal, the sciatic nerve 23 The stimulation transmission to the biceps femoris 6 of the left leg 5 is not properly performed. Therefore, the biosignal is not detected by the stimulation transfer detection electrodes 7a and 7b, or the biosignal to be detected is reduced.
　同様に、一対の刺激印加電極のうちの他方の電極１ｂを仙骨３背面の適切な位置に配置できていない場合には、一対の刺激印加電極１ａと１ｂへ電気刺激を印加しても、坐骨神経２３を介する右脚８の大腿二頭筋６への刺激伝達が適切に行われない。そのため、刺激伝達検出電極１０ａと１０ｂによって生体信号が検出されないか、または検出される生体信号が小さくなる。 Similarly, when the other electrode 1b of the pair of stimulation application electrodes can not be disposed at an appropriate position on the back of the sacrum 3, even if the electric stimulation is applied to the pair of stimulation application electrodes 1a and 1b, The stimulation transmission to the biceps femoris 6 of the right leg 8 through the nerve 23 is not properly performed. Therefore, the biosignal is not detected by the stimulation transfer detection electrodes 10a and 10b, or the biosignal to be detected is reduced.
　測定部１５で測定された生体信号は、制御部１６に伝えられる。制御部１６は、測定部１５による測定結果を表示手段１７に表示する。表示手段１７に表示される測定結果とは、測定部１５による生体信号の測定値自体であってもよいし；当該測定値に基づいて仙骨またはこの仙骨近傍を通る神経に適切な刺激が伝達されているか否かの判断であってもよいし；あるいは、一対の刺激印加電極１ａと１ｂが仙骨３背面部分の適切な位置に配置されているか否かの判断であってもよい。 The biological signal measured by the measurement unit 15 is transmitted to the control unit 16. The control unit 16 displays the measurement result by the measurement unit 15 on the display unit 17. The measurement result displayed on the display means 17 may be the measurement value itself of the biosignal by the measurement unit 15; based on the measurement value, an appropriate stimulus is transmitted to the sacrum or a nerve passing through this sacrum. Or the pair of stimulation applying electrodes 1a and 1b may be determined as to whether or not they are disposed at appropriate positions on the back surface of the sacrum 3 or not.
　適切な刺激が伝達されているか否か、または適切な配置がされているか否かの判断は、例えば、以下の方法で行うことができる。
　１）測定されるべき生体信号の大きさ（電位差）の下限基準値を予め設定しておき、実測した生体信号の大きさ（電位差）が下限基準値を超えているかどうかを基準にして、制御部１６が判断する。
　２）生体信号が測定されるまでの時間帯（潜時）を予め設定しておき、実測された生体信号が設定した時間帯（潜時）に測定できたかどうかを基準にして、制御部１６が判断する。生体信号が測定されるまでの時間帯は、刺激印加電極による仙骨３背面への刺激印加時刻（０ミリ秒）から、約１０ミリ秒～３０ミリ秒経過時までに設定することが望ましい。 The determination as to whether or not the appropriate stimulus has been transmitted or whether or not the appropriate arrangement has been made can be made, for example, in the following manner.
1) The lower limit reference value of the size (potential difference) of the biological signal to be measured is set in advance, and control is performed based on whether the measured magnitude (potential difference) of the biological signal exceeds the lower limit reference value The part 16 makes a decision.
2) A time zone (latency time) until the biomedical signal is measured is set in advance, and the control unit 16 is determined based on whether the measured biomedical signal can be measured in the set time zone (latency time) Will judge. It is desirable to set the time period until the biomedical signal is measured from about 10 milliseconds to 30 milliseconds after the stimulation application time (0 milliseconds) to the back of the sacrum 3 by the stimulation application electrode.
　例えば、左脚５に配置された刺激伝達検出電極７ａと７ｂで検出した生体信号が、設定した時間帯（潜時）よりも極めて短時間もしくは長時間後に測定された場合には、制御部１６が、刺激印加電極１ａからの刺激伝達が不適切である旨を表示手段１７に表示するか、もしくは刺激印加電極１ａの配置が不適切である旨を表示手段１７に表示する。 For example, when the biological signal detected by the stimulation transfer detection electrodes 7a and 7b disposed on the left leg 5 is measured after an extremely short time or a long time from the set time zone (latency time), the control unit 16 However, the display means 17 displays that the stimulation transmission from the stimulation application electrode 1a is inappropriate, or displays that the arrangement of the stimulation application electrode 1a is inappropriate.
　一方、刺激伝達検出電極７ａと７ｂで検出した生体信号が、設定した時間帯（潜時）付近で測定された場合には、実測された生体信号の大きさ（電位差）と、設定した生体信号の大きさ（電位差）の下限基準値とを比較する。 On the other hand, when the biological signal detected by the stimulation transfer detection electrodes 7a and 7b is measured in the vicinity of the set time zone (latency), the size (potential difference) of the measured biological signal and the set biological signal The lower reference value of the magnitude (potential difference) of
　実測された生体信号の大きさが、設定した下限基準値よりも小さい場合には、制御部１６が刺激印加電極１ａからの刺激伝達が不適切である旨を表示手段１７に表示するか、もしくは刺激印加電極１ａの配置が不適切である旨を表示手段１７に表示する。一方、実測された生体信号の大きさが、制御部１６に設定した生体信号の下限基準値よりも大きい場合には、制御部１６が、刺激印加電極１aからの刺激伝達が適切である旨を表示手段１７に表示するか、もしくは刺激印加電極１aの配置が適切である旨を表示手段１７に表示する。 When the magnitude of the measured biological signal is smaller than the set lower limit reference value, the control unit 16 displays on the display means 17 that the stimulation transmission from the stimulation applying electrode 1a is inappropriate, or The display means 17 displays that the arrangement of the stimulation applying electrodes 1a is inappropriate. On the other hand, when the magnitude of the measured biological signal is larger than the lower limit reference value of the biological signal set in the control unit 16, the control unit 16 indicates that the stimulation transmission from the stimulation applying electrode 1a is appropriate. It is displayed on the display means 17, or displayed on the display means 17 that the arrangement of the stimulation applying electrode 1a is appropriate.
　同様に、右脚８に配置された刺激伝達検出電極１０ａと１０ｂで検出した生体信号が、設定した時間帯（潜時）よりも極めて短時間もしくは長時間後に測定された場合には、制御部１６が、刺激印加電極１ｂからの刺激伝達が不適切である旨を表示手段１７に表示するか、もしくは刺激印加電極１ｂの配置が不適切である旨を表示手段１７に表示する。 Similarly, when the biological signals detected by the stimulation transfer detection electrodes 10a and 10b disposed on the right leg 8 are measured after an extremely short time or a long time from the set time zone (latency), the control unit The display 16 displays on the display means 17 that the stimulation transmission from the stimulation applying electrode 1b is inappropriate, or displays on the display 17 that the arrangement of the stimulation application electrode 1b is inappropriate.
　刺激伝達検出電極１０ａと１０ｂで検出した生体信号が、設定した時間帯（潜時）付近で測定された場合には、実測された生体信号の大きさ（電位差）と、設定した生体信号の大きさ（電位差）の下限基準値とを比較する。 When the biological signals detected by the stimulation transfer detection electrodes 10a and 10b are measured in the vicinity of a set time zone (latency), the magnitude (potential difference) of the measured biological signal and the magnitude of the set biological signal Compare with the lower reference value of the distance (potential difference).
　実測された生体信号の大きさが、設定した下限基準値よりも小さい場合には、制御部１６が刺激印加電極１ｂからの刺激伝達が不適切である旨を表示手段１７に表示するか、もしくは刺激印加電極１ｂの配置が不適切である旨を表示手段１７に表示する。一方、実測された生体信号の大きさが、制御部１６に設定した生体信号の下限基準値よりも大きい場合には、制御部１６が、刺激印加電極１ｂからの刺激伝達が適切である旨を表示手段１７に表示するか、もしくは刺激印加電極１ｂの配置が適切である旨を表示手段１７に表示する。 When the magnitude of the measured biological signal is smaller than the set lower limit reference value, the control unit 16 displays on the display means 17 that the stimulation transmission from the stimulation applying electrode 1b is inappropriate, or The display means 17 displays that the arrangement of the stimulation applying electrode 1b is inappropriate. On the other hand, when the magnitude of the measured biological signal is larger than the lower limit reference value of the biological signal set in the control unit 16, the control unit 16 indicates that the stimulation transmission from the stimulation applying electrode 1b is appropriate. It is displayed on the display means 17 or displayed on the display means 17 that the arrangement of the stimulation applying electrode 1b is appropriate.
　また、測定部１５で測定された信号が、刺激信号に応答して発生する生体信号であるのか、またはノイズであるのかを判別しにくい場合もある。そこで、測定部１５による信号の測定を複数回行ってもよい。つまり、刺激伝達検出電極７ａと７ｂおよび刺激伝達検出電極１０ａと１０ｂで検出される生体信号を複数回測定し、複数の測定値を加算平均処理する工程を含んでもよい。この場合、加算平均処理後の生体信号が、設定した時間帯（潜時）において測定されたか、および設定した生体信号の大きさ（電位差）の下限基準値よりも大きいかを基準にして、適切な刺激がなされているか、または適切に刺激印加電極が配置されているかの判断を行う。 In addition, it may be difficult to determine whether the signal measured by the measurement unit 15 is a biological signal generated in response to a stimulation signal or noise. Therefore, the measurement of the signal by the measurement unit 15 may be performed multiple times. That is, the process may include the steps of measuring the biological signals detected by the stimulation transfer detection electrodes 7a and 7b and the stimulation transfer detection electrodes 10a and 10b a plurality of times and averaging the plurality of measured values. In this case, it is appropriate based on whether the biological signal after the averaging process is measured in the set time zone (latency) or larger than the lower limit reference value of the set size (potential difference) of the biological signal. To determine if the stimulation has been performed or if the stimulation electrode has been properly placed.
　さらに、実施の形態１の排尿障害治療器による治療において、左脚５に配置された刺激伝達検出電極７ａおよび７ｂが検出する生体信号Ｘと、右脚８に配置された刺激伝達検出電極１０ａおよび１０ｂが検出する生体信号Ｙとを比較してもよい。つまり、生体信号Ｘが検出されるまでの時間（潜時）と生体信号Ｙが検出されるまでの時間（潜時）とを比較するか；または生体信号Ｘの大きさ（電位差）と生体信号Ｙの大きさ（電位差）とを比較してもよい。比較した潜時または電位差に大きな差異がある場合には、その潜時または電位の差異が小さくなるように、一対の刺激印加電極１ａと１ｂの配置状態を調整する。それにより、一対の刺激印加電極１ａと１ｂをより適切な配置関係として、治療効果を高めることができる。 Furthermore, in the treatment by the urination disorder treatment device of the first embodiment, the biosignal X detected by the stimulation transmission detection electrodes 7a and 7b disposed in the left leg 5, the stimulation transmission detection electrode 10a disposed in the right leg 8, and You may compare with the biological signal Y which 10b detects. That is, the time until the biosignal X is detected (latency) and the time until the biosignal Y is detected (latency) are compared; or the magnitude (potential difference) of the biosignal X and the biosignal The magnitude (potential difference) of Y may be compared. If there is a large difference in the compared latency or potential difference, the arrangement of the pair of stimulus applying electrodes 1a and 1b is adjusted so that the difference in latency or potential is reduced. Thereby, the therapeutic effect can be enhanced by setting the pair of stimulation applying electrodes 1a and 1b in a more appropriate arrangement relationship.
　前記の通り、操作部２９での操作に応じて制御部１６は、一対の刺激印加電極１ａと１ｂが印加する刺激信号の大きさを調整することができる。刺激信号の大きさの調整によっても、刺激伝達検出電極７ａと７ｂで検出した生体信号、および刺激伝達検出電極１０ａと１０ｂで検出した生体信号が、設定した下限基準値よりも大きな値になるようにすることができる。 As described above, the control unit 16 can adjust the magnitude of the stimulation signal applied by the pair of stimulation applying electrodes 1a and 1b according to the operation of the operation unit 29. By adjusting the magnitude of the stimulation signal, the biological signals detected by the stimulation transfer detection electrodes 7a and 7b and the biological signals detected by the stimulation transmission detection electrodes 10a and 10b become values larger than the set lower limit reference value. Can be
　刺激信号の大きさの調整は、患者個人に合わせて行われる。排尿障害を緩和させる治療効果を得るために適当な刺激信号の大きさは、患者個人ごとに異なるからである。そのため、患者個人の治療効果を確認しながら、一対の刺激印加電極１ａと１ｂが印加する双極性矩形波パルス信号の大きさを調整することが好ましい。 Adjustment of the magnitude of the stimulation signal is tailored to the individual patient. The reason is that the magnitude of the stimulus signal suitable for obtaining a therapeutic effect to alleviate urination disorder varies from patient to patient. Therefore, it is preferable to adjust the magnitude of the bipolar rectangular wave pulse signal applied by the pair of stimulus applying electrodes 1a and 1b while confirming the treatment effect of the individual patient.
　また、使用者は、表示手段１７に表示された情報により、適切な刺激伝達ができているか否かを確認することができる。つまり、一対の刺激印加電極１ａと１ｂを介して与えた刺激による治療効果を実感しつつ治療を行うことができる。 Further, the user can confirm whether the appropriate stimulation can be transmitted or not by the information displayed on the display means 17. That is, treatment can be performed while realizing the therapeutic effect of the stimulation given via the pair of stimulation applying electrodes 1a and 1b.
　以下において、刺激伝達検出電極の配置態様が実施の形態１とは異なる形態を、実施の形態２～４で説明する。一方、実施の形態２～４の排尿障害治療器の刺激伝達検出電極以外の部材は、実施の形態１の排尿障害治療器の部材と同様であるので、説明を割愛する。 In the following, modes in which the arrangement mode of the stimulation transfer detection electrode is different from that of the first embodiment will be described in the second to fourth embodiments. On the other hand, since the members other than the stimulation transfer detection electrode of the urination disorder treatment device of the second to fourth embodiments are the same as the members of the urination disorder treatment device of the first embodiment, the description will be omitted.
　［実施の形態２］
　図４は、本発明の実施の形態２における排尿障害治療器を示す。実施の形態２の排尿障害治療器の刺激伝達検出電極は、大腿二頭筋６と９（図３参照）よりも内側に存在する半腱様筋３０と３１の背面に配置されている。すなわち、刺激伝達検出電極７ａと７ｂを、左脚５の半腱様筋３０の背面に配置し；かつ刺激伝達検出電極１０ａと１０ｂを、右脚８の半腱様筋３１の背面に配置している。 Second Embodiment
FIG. 4 shows the urination disorder treatment device in the second embodiment of the present invention. The stimulation transfer detection electrode of the urination disorder treatment device of the second embodiment is disposed on the back of the semitendinoid muscles 30 and 31 present inside the biceps femoris 6 and 9 (see FIG. 3). That is, the stimulation transfer detection electrodes 7a and 7b are disposed on the back of the semitendinoid muscle 30 of the left leg 5; and the stimulation transmission detection electrodes 10a and 10b are disposed on the back of the semitendinoid muscle 31 of the right leg 8. ing.
　図１および図２に示すように、坐骨神経２３は仙骨孔１８を通っている。そして、図４に示されるように、坐骨神経２３由来の筋肢は、下方の左脚５の半腱様筋３０と、右脚８の半腱様筋３１につながっている。 As shown in FIGS. 1 and 2, the sciatic nerve 23 passes through the sacral foramen 18. Then, as shown in FIG. 4, the muscle limb derived from the sciatic nerve 23 is connected to the semitendinoid muscle 30 of the lower left leg 5 and the semitendinoid muscle 31 of the right leg 8.
　そのため、左脚５の半腱様筋３０の背面に配置された刺激伝達検出電極７ａと７ｂ、および右脚８の半腱様筋３１の背面に配置された刺激伝達検出電極１０ａと１０ｂで検出した生体信号を測定することにより、一対の刺激印加電極１ａと１ｂの配置状態が適切かどうかを判定することができる。生体信号を測定するとは、前記の通り、生体信号の潜時と大きさ（電位差）を測定することを含む。 Therefore, detection is performed by the stimulation transfer detection electrodes 7a and 7b disposed on the back of the semitendinoid muscle 30 of the left leg 5 and the stimulation transmission detection electrodes 10a and 10b disposed on the back of the semitenoid muscle 31 of the right leg 8 It is possible to determine whether or not the arrangement of the pair of stimulus applying electrodes 1a and 1b is appropriate by measuring the biosignals obtained. As described above, measuring the biological signal includes measuring the latency and the magnitude (potential difference) of the biological signal.
　［実施の形態３］
　図５は、本発明の実施の形態３における排尿障害治療器を示す。実施の形態３の排尿障害治療器の刺激伝達検出電極は、大腿二頭筋６と９（図３参照）や、半腱様筋３０と３１（図４参照）よりも下肢遠位部に存在する、腓腹筋２４と２５の背面に配置されている。すなわち、刺激伝達検出電極７ａと７ｂを左脚５の腓腹筋２４の背面に配置し；刺激伝達検出電極１０ａと１０ｂを右脚８の腓腹筋２５の背面に配置している。 Third Embodiment
FIG. 5 shows the urination disorder treatment device in the third embodiment of the present invention. The stimulation transfer detection electrodes of the urination disorder treatment device of the third embodiment are present in the distal portion of the lower extremity than the biceps femoris 6 and 9 (see FIG. 3) and the semitendinoid muscles 30 and 31 (see FIG. 4). , Located on the back of gastrocnemius 24 and 25. That is, the stimulation transfer detection electrodes 7a and 7b are disposed on the back of the gastrocnemius muscle 24 of the left leg 5, and the stimulation transmission detection electrodes 10a and 10b are disposed on the back of the gastrocnemius muscle 25 of the right leg 8.
　図１および図２に示すように、坐骨神経２３は仙骨孔１８を通っている。そして、図５に示すように、坐骨神経２３は下方で総腓骨神経２６と脛骨神経２７とに分岐する。脛骨神経２７の筋枝が、それぞれ腓腹筋２４および２５につながっている。 As shown in FIGS. 1 and 2, the sciatic nerve 23 passes through the sacral foramen 18. Then, as shown in FIG. 5, the sciatic nerve 23 branches downward to the common peroneal nerve 26 and the tibial nerve 27. Muscle branches of the tibial nerve 27 are connected to the gastrocnemius muscles 24 and 25, respectively.
　そのため、左脚５の腓腹筋２４の背面に配置された刺激伝達検出電極７ａと７ｂ、および右脚８の腓腹筋２５の背面に配置された刺激伝達検出電極１０ａと１０ｂで検出した生体信号を測定することにより、一対の刺激印加電極１ａと１ｂの配置状態が適切かどうかを判定することができる。生体信号を測定するとは、前記の通り、生体信号の潜時と大きさ（電位差）を測定することを含む。 Therefore, the biomedical signals detected by the stimulation transfer detection electrodes 7a and 7b disposed on the back of the gastrocnemius 24 of the left leg 5 and the stimulation transmission detection electrodes 10a and 10b disposed on the back of the gastrocnemius 25 of the right leg 8 are measured. Thus, it can be determined whether the arrangement of the pair of stimulation applying electrodes 1a and 1b is appropriate. As described above, measuring the biological signal includes measuring the latency and the magnitude (potential difference) of the biological signal.
　［実施の形態４］
　図６は、本発明の実施の形態４における排尿障害治療器を示す。実施の形態４の排尿障害治療器の刺激伝達検出電極は、腓腹筋２４と２５（図５参照）よりも遠位の後外側にあるヒラメ筋３３と３４の背面に配置されている。すなわち、刺激伝達検出電極７ａと７ｂを、左脚５のヒラメ筋３３の背面に配置し；刺激伝達検出電極１０ａと１０ｂを、右脚８のヒラメ筋３４の背面に配置している。 Fourth Embodiment
FIG. 6 shows the urination disorder treatment device in the fourth embodiment of the present invention. The stimulation transmitting detection electrodes of the urination disorder treatment device of the fourth embodiment are disposed on the back of soleus muscles 33 and 34 which are more on the back outside than the gastrocnemius muscles 24 and 25 (see FIG. 5). That is, the stimulation transfer detection electrodes 7a and 7b are disposed on the back of the flatfish muscle 33 of the left leg 5, and the stimulation transmission detection electrodes 10a and 10b are disposed on the back of the flatfish muscle 34 of the right leg 8.
　図１および図２に示すように、坐骨神経２３は仙骨孔１８を通っている。そして、図６に示されるように、坐骨神経２３は下方で総腓骨神経２６と脛骨神経２７へと分岐する。脛骨神経２７の筋枝が、それぞれヒラメ筋３３および３４につながっている。 As shown in FIGS. 1 and 2, the sciatic nerve 23 passes through the sacral foramen 18. And, as shown in FIG. 6, the sciatic nerve 23 branches downward to the common peroneal nerve 26 and the tibial nerve 27. The branches of the tibial nerve 27 are connected to the soleus muscles 33 and 34 respectively.
　そのため、左脚５のヒラメ筋３３の背面に配置された刺激伝達検出電極７ａ、７ｂ、および右脚８のヒラメ筋３４の背面に配置された刺激伝達検出電極１０ａ、１０ｂで検出した生体信号を測定することにより、一対の刺激印加電極１ａと１ｂの配置状態が適切かどうかを判定することができる。生体信号を測定するとは、前記の通り、生体信号の潜時と大きさ（電位差）を測定することを含む。 Therefore, the biomedical signals detected by the stimulation transfer detection electrodes 7a and 7b disposed on the back of the flatfish muscle 33 of the left leg 5 and the stimulation transfer detection electrodes 10a and 10b disposed on the back of the flatfish muscle 34 of the right leg 8 are By measuring, it is possible to determine whether the arrangement of the pair of stimulus applying electrodes 1a and 1b is appropriate. As described above, measuring the biological signal includes measuring the latency and the magnitude (potential difference) of the biological signal.
　以上のように本発明の排尿障害治療器は、仙骨背面側に所定間隔をおいて配置される少なくとも一対の刺激印加電極を介して、仙骨部の排尿反射中枢を通る蓄排尿をつかさどる神経へ刺激信号を伝えることで、排尿障害を治療する。
　そして、本発明の排尿障害治療器は刺激伝達検出電極を有し、前記刺激信号に応答して発生する生体信号を検出することができる。その生体信号を測定することで、適切な生体信号が与えられているかを表示手段に表示することができる。治療者は、前記表示を確認しながら、適切な刺激信号を与えられるように一対の刺激印加電極の配置位置を適切に調整することができる。それにより適切な治療を実現する。 As described above, the urinating disorder treatment device according to the present invention stimulates the nerve that controls urination passing through the urination reflex center of the sacral region via at least a pair of stimulation application electrodes arranged at a predetermined interval on the back side of the sacrum. Treat the urination disorder by transmitting a signal.
And the urination disorder treatment device of the present invention has a stimulation transfer detection electrode, and can detect a biosignal generated in response to the stimulation signal. By measuring the biological signal, it can be displayed on the display means whether the appropriate biological signal is given. While confirming the display, the therapist can appropriately adjust the arrangement position of the pair of stimulation electrodes so as to give an appropriate stimulation signal. It realizes appropriate treatment.
　また、本発明の排尿障害治療器が刺激信号の強さを調整する操作部を有していれば；治療者は、前記表示を確認しながら、適切な刺激信号を与えられるように前記操作部を操作して刺激信号の強さを調整し、患者にとって適切な刺激を与えることができる。 In addition, if the urinating disorder treatment device of the present invention has an operation unit for adjusting the strength of the stimulation signal; the treatment person can give the appropriate stimulation signal while confirming the display. To adjust the strength of the stimulation signal to give the patient appropriate stimulation.
　以上の通り、本発明の排尿障害治療器は、より効果的な排尿障害治療を実現することができる。 As described above, the urination disorder treatment device of the present invention can realize more effective urination disorder treatment.
　本出願は、２００９年９月１７日に出願された日本特許出願第２００９－２１５３６１号に基づく優先権を主張する。当該出願の明細書、特許請求の範囲および図面に記載された事項は、全て本出願に援用される。 This application claims priority based on Japanese Patent Application No. 2009-215361 filed on Sep. 17, 2009. All the contents described in the specification, claims and drawings of the application are incorporated in the present application.
　１ａ、１ｂ　一対の刺激印加電極
　２　人体
　３　仙骨
　４　刺激信号供給源
　５　左脚
　６,９　大腿二頭筋
　７ａ,７ｂ　刺激伝達検出電極
　８　右脚
　１０ａ,１０ｂ　刺激伝達検出電極
　１１,１３　大腿二頭筋短頭
　１２,１４　大腿二頭筋長頭
　１５　測定部
　１６　制御部
　１７　表示手段
　１８　仙骨孔
　１９　膀胱
　２０　骨盤内臓神経
　２１　尿道括約筋
　２２　陰部神経
　２３　坐骨神経
　２４,２５　腓腹筋
　２６　総腓骨神経
　２７　脛骨神経
　２８　下腹神経
　２９　操作部
　３０,３１　半腱様筋
　３２　接地電極
　３３,３４　ヒラメ筋 1a, 1b Pair of stimulation application electrodes 2 Human body 3 Sacral 4 Stimulation signal source 5 Left leg 6, 9 Femoral muscle 7a, 7b Stimulation transmission detection electrode 8 Right leg 10a, 10b Stimulation transmission detection electrode 11, 13 Two femur Muscle short head 12, 14 Biceps femoris long head 15 Measurement part 16 Control part 17 Display means 18 Sacral borehole 19 Bladder 20 Pelvic visceral nerve 21 Urethral sphincter muscle 22 Genital nerve 23 Sciatic nerve 24, 25 gastrocnemius 26 Total peroneal nerve 27 Tibial nerve 28 lower abdominal nerve 29 operation part 30, 31 half tendon like muscle 32 ground electrode 33, 34 solei muscle

Claims (9)

  1. 　患者の排尿障害を治療するための排尿障害治療器であって、
    　　　患者の仙骨背面に所定間隔を介して配置され、仙骨背面に刺激信号を供給する少なくとも一対の刺激印加電極と、
    　　　前記一対の刺激印加電極が刺激信号を供給するための刺激信号供給源と、
    　　　前記仙骨または前記仙骨近傍を通る神経がつながっている組織付近に配置され、前記刺激信号に応答して発生する生体信号を検出する刺激伝達検出電極と、
    　　　前記患者の任意の皮膚上に配置される接地電極と、
    　　　前記刺激伝達検出電極と前記接地電極とに接続され、前記刺激伝達検出電極が検出する生体信号を測定する測定部と、
    　　　前記測定部に接続され、測定部の測定結果に基づき前記一対の刺激印加電極による前記刺激信号の供給を制御する制御部と、
    　　　前記制御部に接続され、前記測定部による測定結果を表示される表示手段と、
    　を備える構成とした排尿障害治療器。     A urination disorder treatment unit for treating urination disorder of a patient, comprising
    At least one pair of stimulation electrodes disposed on the back of the patient's sacrum via a predetermined interval and supplying stimulation signals to the back of the sacrum;
    A stimulation signal source for the pair of stimulation electrodes to supply a stimulation signal;
    A stimulation transfer detection electrode which is disposed in the vicinity of a tissue connected by a nerve passing through the sacrum or the vicinity of the sacrum, and detecting a biosignal generated in response to the stimulation signal;
    A ground electrode disposed on any skin of the patient;
    A measurement unit connected to the stimulation transfer detection electrode and the ground electrode for measuring a biological signal detected by the stimulation transfer detection electrode;
    A control unit connected to the measurement unit and controlling supply of the stimulation signal by the pair of stimulation application electrodes based on the measurement result of the measurement unit;
    A display unit connected to the control unit and displaying a measurement result by the measurement unit;
    The urination disorder treatment device was configured to include.
  2. 　前記測定部は、前記刺激印加電極から仙骨背面に供給された刺激信号に対応して誘発された誘発電位を測定する構成とした、請求項１に記載の排尿障害治療器。 The urination disorder treatment device according to claim 1, wherein the measurement unit is configured to measure an evoked potential induced in response to a stimulation signal supplied from the stimulation application electrode to the sacral dorsal surface.
  3. 　前記仙骨または前記仙骨近傍を通る神経は坐骨神経である、請求項１に記載の排尿障害治療器。 The urination disorder treatment device according to claim 1, wherein the nerve passing through the sacrum or the vicinity of the sacrum is a sciatic nerve.
  4. 　前記刺激伝達検出電極は、左脚および右脚それぞれの大腿二頭筋背面に２つずつ配置する構成とした、請求項１に記載の排尿障害治療器。 The urination disorder treatment device according to claim 1, wherein the stimulation transfer detection electrodes are disposed two each on the back of the biceps femoris muscle of each of the left leg and the right leg.
  5. 　前記刺激伝達検出電極は、左脚および右脚それぞれの半腱様筋背面に２つずつ配置する構成とした、請求項１に記載の排尿障害治療器。 The urination disorder treatment device according to claim 1, wherein the stimulation transfer detection electrodes are disposed two each on the back of the semitendinoid muscle of each of the left leg and the right leg.
  6. 　前記刺激伝達検出電極は、左脚および右脚それぞれの腓腹筋背面に２つずつ配置する構成とした、請求項１に記載の排尿障害治療器。 The urination disorder treatment device according to claim 1, wherein the stimulation transfer detection electrodes are disposed two each on the back of the gastrocnemius muscle of each of the left leg and the right leg.
  7. 　前記刺激伝達検出電極は、左脚および右脚それぞれのヒラメ筋背面に２つずつ配置する構成とした、請求項１に記載の排尿障害治療器。 The urination disorder treatment device according to claim 1, wherein the stimulation transfer detection electrodes are disposed two each on the back surface of the flatfish muscle of each of the left leg and the right leg.
  8. 　前記制御部は、前記測定部が測定した生体信号の大きさに基づき、前記刺激印加電極が供給する刺激信号の大きさを制御する構成とした、請求項１に記載の排尿障害治療器。 The urination disorder treatment device according to claim 1, wherein the control unit controls the magnitude of the stimulation signal supplied by the stimulation applying electrode based on the magnitude of the biological signal measured by the measurement unit.
  9. 　前記制御部は、前記測定部が測定した生体信号の大きさに基づき、前記表示手段に表示を行う構成とした、請求項１に記載の排尿障害治療器。
          The urination disorder treatment device according to claim 1, wherein the control unit performs display on the display unit based on the size of the biological signal measured by the measurement unit.
PCT/JP2010/005550 2009-09-17 2010-09-10 Treatment device for urination disorders WO2011033750A1 (en)

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US13/496,694 US20120197339A1 (en) 2009-09-17 2010-09-10 Treatment device for urination disorders
DE112010003698T DE112010003698T5 (en) 2009-09-17 2010-09-10 Device for the treatment of urinary dysfunction

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